JP7581353B2 - Navigation Trocar with Internal Camera - Patent application - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
This application is related to U.S. patent application entitled "Trocar with Modular Trocar Obturator Head," filed on even date herewith, attorney docket number BIO6225USNP1, the disclosure of which is incorporated herein by reference.

FIELD OF THEINVENTION
The present invention relates generally to invasive medical tools, and more particularly to invasive medical tools incorporating a camera.

Techniques for image-guided probing of a patient's organs have previously been proposed in the patent literature. For example, U.S. Patent Application Publication No. 2011/0160535 describes a disposable access port for use in endoscopic procedures, including laparoscopic procedures. The access port includes a cannula having an embedded external camera that communicates with an external control box. The camera may be fixedly or adjustably attached to the port. The external camera may also be attached to a trocar for use with the access port. The trocar may include irrigation and aspiration channels to facilitate clear viewing of the anatomical site.

As another example, U.S. Patent Application Publication No. 2013/0282041 describes a viewing trocar assembly that includes a tubular body having a proximal end and a distal end, an opening at the distal end, and at least one external imaging device disposed on an outer wall of the distal end of the tubular body, where the at least one imaging device is adjacent to the outer wall of the distal end of the tubular body when in an inactivated position, and where the at least one imaging device extends further from the outer wall of the distal end of the tubular body when in an activated position than when in the inactivated position.

Different trocars have previously been proposed in the patent literature. For example, U.S. Patent No. 5,807,338 describes a modular trocar system that includes an obturator assembly and a cannula assembly defining a longitudinal passage configured and dimensioned to slidably receive the obturator assembly. A method of assembly is also provided.

As another example, U.S. Patent No. 5,405,328 describes a kit assembly for use in constructing a desired trocar obturator for use during a surgical procedure. The kit includes a proximal portion of the obturator and multiple different distal end portions. The proximal portion may be releasably attached to the distal portion by a detent mechanism. Reuse of the proximal portion allows for potential cost savings. Multiple distal end portions allow the surgeon to choose from different trocar tips, thereby allowing the trocar to be customized for a particular surgical procedure.

One embodiment of the present invention provides a trocar for insertion into an organ of a patient, the trocar including a cannula, a channel within the cannula, and a camera. The cannula has a longitudinal axis, and the channel within the cannula is mounted parallel to the longitudinal axis. The camera is disposed at a distal end of the channel and configured to provide an image in the direction of a distal opening of the cannula.

In some embodiments, the camera is tilted relative to the longitudinal axis to have a line of sight that captures the distal opening of the cannula.

In some embodiments, the trocar further includes a position sensor that is positioned at the distal end of the channel without obstructing the camera's field of view and configured to generate a signal indicative of the position of the distal end in the organ.

In one embodiment, the position sensor is a magnetic position sensor.

According to another embodiment of the present invention, there is further provided a system including a trocar and a processor. The trocar is configured for insertion into an organ of a patient and includes a cannula, a channel within the cannula, a camera, and a position sensor. The cannula has a longitudinal axis and the channel within the cannula is mounted parallel to the longitudinal axis. The camera is disposed at a distal end of the channel and configured to provide an image in the direction of a distal opening of the cannula. The position sensor is disposed at the distal end of the channel without obstructing the camera's field of view and configured to generate a signal indicative of a position of the distal end in the organ. The processor is configured to estimate a position of the distal end of the trocar in the organ using the signal generated by the position sensor.

In some embodiments, the processor is further configured to align the image acquired by the camera to a reference medical image based on the estimated position, and present the mutually aligned image acquired by the camera and the reference medical image to a user.

According to another embodiment of the present invention, there is further provided a method including inserting a trocar into an organ of a patient, the trocar including a cannula, a channel within the cannula, a camera, and a position sensor. The cannula has a longitudinal axis, and the channel within the cannula is mounted parallel to the longitudinal axis. The camera is disposed at a distal end of the channel and configured to provide an image in the direction of a distal opening of the cannula. The position sensor is disposed at the distal end of the channel without obstructing the field of view of the camera, and configured to generate a signal indicative of the position of the distal end within the organ. The generated signal is used to estimate the position of the distal end of the trocar within the organ.

In some embodiments, the method further includes aligning the image acquired by the camera to a reference medical image based on the estimated position. The mutually aligned image acquired by the camera and the reference medical image are presented to a user.

Another embodiment of the present invention provides a trocar for insertion into an organ of a patient, the trocar including a cannula, an obturator body, and two or more interchangeable obturator heads. The cannula has a longitudinal axis. The obturator body is configured to be inserted into the cannula. Each of the two or more interchangeable obturator heads is configured to be removably attached to a distal end of the obturator body.

In some embodiments, the obturator heads have different geometries for penetrating different tissue types.

In some embodiments, the interchangeable obturator head is configured for use in an invasive brain procedure.

In one embodiment, the trocar further includes a channel in the cannula, a camera, and a position sensor. The channel in the cannula is mounted parallel to the longitudinal axis. The camera is disposed at a distal end of the channel and configured to provide an image in the direction of the distal opening of the cannula. The position sensor is disposed at the distal end of the channel without obstructing the field of view of the camera and configured to generate a signal indicative of the position of the distal end in the organ.

In another embodiment, the camera is tilted to have a central line of sight direction of the camera pointing to the center of the distal opening of the cannula. In yet another embodiment, the position sensor is a magnetic position sensor.

In some embodiments, the obturator body includes a recess so that the obturator body fits into a channel in the cannula when the obturator body is inserted into the cannula.

In some embodiments, the interchangeable obturator heads each include a recess to fit into a channel in the cannula when the obturator is inserted into the cannula.

According to another embodiment of the present invention, a method is further provided that includes selecting an obturator head from among two or more interchangeable obturator heads. The selected obturator head is removably attached to a distal end of the obturator body to form an obturator. A trocar is assembled by attaching the obturator to a cannula. The trocar is inserted into an organ of the patient to perform a medical procedure on the patient.

In some embodiments, the method further includes acquiring an image in the direction of a distal opening of the cannula with a camera disposed at the distal end of the cannula. Using a position sensor disposed at the distal end of the channel without obstructing the camera's field of view, a signal is generated indicative of the position of the distal end in the organ. The generated signal is used to estimate the position of the distal end of the trocar in the organ.

In some embodiments, the method further includes aligning the image acquired by the camera to a reference medical image based on the estimated position. The mutually aligned image acquired by the camera and the reference medical image are presented to a user.

The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken in conjunction with the drawings.

1 is a schematic diagram of a brain procedure using a surgical device with a trocar including a camera and a position sensor, according to one embodiment of the present invention. 2 is a schematic diagram of a trocar applied in the brain procedure of FIG. 1, in accordance with one embodiment of the present invention. 3 is a flow chart that generally illustrates a method and algorithm for registering a visual image from a camera of the trocar of FIG. 2 to a reference medical image, in accordance with an embodiment of the present invention. 2 is a schematic diagram of a trocar applied in the brain procedure of FIG. 1 according to another embodiment of the present invention. 5 is a flow chart that generally illustrates a method of using the trocar of FIG. 4 having an interchangeable obturator head, in accordance with one embodiment of the present invention.

In some invasive procedures, a trocar, which functions as a through portal, is first placed at an entry location to insert a medical probe or other tool into the patient's body. In addition to being a portal for the probe, the trocar, which contains a cannula, is used for irrigation and drainage of bodily fluids and other fluids. Typically, an obturator is first inserted through the cannula so that it can penetrate the body and create access for the probe.

Such invasive medical procedures typically require the use of dedicated imaging to guide a medical probe to/within an organ, such as the brain, e.g., using an x-ray system and/or a camera attached to the probe. In some cases, for example, a brain procedure may require navigating the distal end of a probe that is inserted into the brain through a hole drilled in the skull. A therapeutic probe must be advanced through a trocar and guided to treat the target brain tissue, e.g., infected or bleeding brain tissue.

However, therapeutic probes are often space-limited and require visual guidance of the probe regardless of other probe navigation techniques. In addition, the trocars themselves are traditionally inserted "blind," meaning the inserting physician does not know exactly where the distal end of the trocar is. The physician also cannot see the tissue the trocar is contacting.

Embodiments of the invention described below provide a trocar having a camera for viewing the target tissue and/or a therapeutic probe mounted inside the wall of the cannula. In some embodiments, a position sensor is also mounted inside the wall of the cannula. Sensor wiring providing position data from the sensor runs along with the camera wiring from the sensor to a processor, which provides position data of the trocar distal end to a physician, for example to register an image captured from the camera to a reference medical image (e.g., an MRI image).

Thus, an internal camera and position sensor (e.g., a magnetic position sensor operating with a position tracking system) within the disclosed cannula allows the physician to view the tissue being penetrated by the trocar, and the sensor allows the distal end of the trocar to be tracked. The camera can then be used for visual guidance of the therapeutic probe.

By optimizing visual image acquisition using an internal camera in the trocar, the disclosed technology can improve the quality of minimally invasive medical procedures.

In general, trocars are relatively expensive since they can usually be precision instruments and must be capable of being sterilized (by autoclaving or otherwise). There are many different types of trocars depending on the task they are designed to perform. For example, a trocar with an obturator for penetrating muscle or bone may have a very sharp obturator head, while a trocar for penetrating brain tissue may have a smooth obturator head in order to open access to the brain as "gently" as possible. As mentioned above, there is a significant expense involved in forming each of these different trocars with their cameras and position sensors.

In some embodiments of the invention, a modular trocar is provided, where the obturator head of the trocar can be selected by the physician according to the obturator task required. The obturator head is sterilizable and reusable. The proximal end, including the camera and position sensor, is a low-cost disposable item, but can be used multiple times during the same procedure by replacing the obturator head, as described below.

System Description Figure 1 is a schematic diagram of a brain procedure using a surgical device 28 with a trocar 38 including a camera 50 and a position sensor 48, according to one embodiment of the present invention. In some embodiments, a brain diagnostic and treatment system 20 including the surgical device 28 is configured to perform a brain procedure, such as treating an infection in brain tissue of a patient 22. In the illustrated embodiment, the trocar 38 is used to penetrate the skull, allowing a physician 24 to insert a probe 39 into the head 41 of the patient 22 (insertion not shown) to access the brain tissue. The probe 39 may then be manipulated using a camera 50 attached to the trocar. Typically, the treatment probe 39 may be further manipulated by a second physician (not shown).

In the illustrated embodiment, the cable 32 enters the proximal end of the trocar 38 and is electrically coupled at its distal end to the camera 50 and the position sensor 48.

The system 20 includes a magnetic position tracking system configured to track the location of the sensor 48 within the brain. The magnetic position tracking system includes a location pad 40 including magnetic field generators 44 fixed to a frame 46. In the exemplary configuration shown in FIG. 1, the pad 40 includes five magnetic field generators 44, but may alternatively include any other suitable number of generators 44. The pad 40 further includes a pillow (not shown) positioned under the head 41 of the patient 22 such that the generators 44 are located at a fixed, known location outside the head 41. The position sensor generates a position signal in response to sensing the external magnetic field generated by the magnetic field generators 44, thereby enabling the processor 34 to estimate the location of the sensor 50, and thus the distal end of the trocar 38 within the head of the patient 22.

This location sensing technology has been implemented in a variety of medical applications, such as the CARTO™ system manufactured by Biosense Webster Inc. (Irvine, Calif.), and is described in detail in U.S. Pat. Nos. 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612, and 6,332,089, WO 96/05768, and U.S. Patent Application Publication Nos. 2002/0065455 (A1), 2003/0120150 (A1), and 2004/0068178 (A1), which are incorporated by reference in their entireties as if fully set forth herein.

In some embodiments, the system 20 includes a console 33 including a memory 49 and a driver circuit 42 configured to drive a magnetic field generator 44 with appropriate signals via a cable 37 to generate a magnetic field within a predetermined working volume in the space surrounding the head 41.

The console 33 may further include additional control elements to assist the physician 24 in performing the procedure, such as command buttons for capturing an image from the camera 50 and registering it to a reference medical image using the position acquired by the magnetic position tracking system.

The processor 34 is typically a general-purpose computer with appropriate front-end and interface circuitry for receiving images from the camera 50 and signals from the position sensor 48 via the cable 32 and for controlling the other components of the system 20 described herein.

In some embodiments, the processor 34 is configured to register the image generated by the camera 50 to a medical image, such as an MRI image. The processor 34 may further register the estimated position of the distal end using the position sensor 48. The processor 34 may register the camera 50 image by estimating the position of the distal end of the trocar 38 using the position sensor 48. The processor 34 is configured to register the camera image and the reference medical image in the coordinate system of the magnetic position tracking system and/or the coordinate system of the reference medical image.

In some embodiments, the system 20 includes a video display 52 that displays an image 55 captured by the camera 50. In the illustrated image, the distal end of the therapeutic probe 39 is seen engaging brain tissue.

In some embodiments, the processor 34 is configured to receive, via an interface (not shown), one or more anatomical images, such as a reference MRI image depicting two-dimensional (2D) slices of the head 41. The processor 34 is configured to select one or more slices from the MRI image, perform registration with a real-time camera image, such as image 55, to generate a combined image, such as image 35, and display the selected combined slices to the physician 24 on the user display 36. In the example of FIG. 1, the combined image 35 shows a cross-sectional coronal view of the forebrain tissue of the patient 22.

The console 33 further includes input devices, such as a keyboard and mouse, for controlling the operation of the console, and a user display 36 configured to display data (e.g., images) received from the processor 34 and/or inputs inserted by a user (e.g., by the physician 24) using the input devices.

For purposes of brevity and clarity, FIG. 1 shows only those elements relevant to the disclosed technology. System 20 typically includes additional or alternative modules and elements not directly related to the disclosed technology, and thus, they have been intentionally omitted from FIG. 1 and the corresponding description.

The processor 34 may be programmed with software to perform functions used by the system and to store in memory 49 data to be processed or otherwise used by the software. The software may be downloaded to the processor in electronic form, for example, over a network, or may be provided on a non-transitory tangible medium, such as an optical, magnetic or electronic memory medium. Alternatively, some or all of the functions of the processor 34 may be performed by dedicated or programmable digital hardware components. In particular, the processor 34 executes dedicated algorithms such as those disclosed herein and included in FIG. 3, which enable the processor 34 to perform the disclosed steps, as further described below.

Navigation Trocar with Internal Camera Figure 2 is a schematic diagram of a trocar 38 applied in the brain procedure of Figure 1, according to one embodiment of the present invention. Trocar 38 includes a cannula 69 and an obturator 60. As can be seen, trocar 38 includes a channel 70 within cannula 69, having a distal end to which camera 50 and position sensor 48 are attached. Channel 70 further provides a track for routing cable 32.

In one embodiment, the camera 50 is angled relative to the longitudinal axis of the trocar 38 so as to have a central distal gaze direction pointing toward the center of the distal opening 78 of the cannula 69. At the same time, the sensor 48 is mounted so as not to obstruct the field of view of the camera 50.

The configuration of trocar 38 in FIG. 2 is shown as an example for conceptual clarity. Other embodiments may include additional elements, such as additional ports in trocar 38 for inserting medical tools into a target brain location.

Figure 3 is a flow chart that generally illustrates a method and algorithm for registering a visual image from the camera 50 of the trocar 38 of Figure 2 to a reference medical image, in accordance with one embodiment of the present invention. The process begins with the physician 24 placing the trocar 38 to access the brain, at a trocar placement step 80.

The physician 24 then operates the system 20 in a trocar position tracking step 82 to magnetically track the position of the distal end of the trocar 38 within the brain using signals from the sensor 48. Then, in an image capture step 84, the physician 24 captures an image with the camera 50 and registers it to the reference medical image.

In an image registration step 86, based on the tracked position of the distal end of the trocar 38 (using the sensor 48), the processor 34 registers the captured image (by the camera 50) to a respective reference medical image stored in the memory 49, such as from an MRI scan, to generate a combined image 35. In one embodiment, the processor 34 is further configured to correct the reference medical image based on the registered image, for example, if the treatment removes brain tissue. In another embodiment, the processor is further configured to alert the user of a detected discrepancy between the visual image and the reference image, for example, due to a larger tumor size detected by the camera 50 due to tumor growth since the reference image was taken.

Next, in a trocar adjustment step 88, using the combined image 35, the physician 24 adjusts the alignment of the trocar 38 to best allow for the best access to the target brain tissue, e.g., infected tissue. The physician 24 then inserts a treatment probe 39 in a probe insertion step 90 to treat the target tissue under visual guidance provided by the camera 50.

The exemplary flow chart shown in FIG. 3 has been selected solely for conceptual clarity. In alternative embodiments, physician 24 may perform additional steps, such as using additional monitoring steps (e.g., fluoroscopy) to verify successful results of the procedure and/or apply irrigation to clarify the view of camera 50.

Navigation Trocar with Internal Camera and Modular Obturator Head Figure 4 is a schematic diagram of a trocar 38 applied in the brain procedure of Figure 1, according to another embodiment of the present invention. Trocar 38 includes a cannula 69 and an obturator 60. As can be seen, trocar 38 includes a modular obturator 60 including an obturator body 79 configured to be inserted into the cannula 69 of trocar 38. An obturator head 102 of obturator 60 is configured to penetrate the body to create access for a probe.

The obturator body 79 of the modular obturator 60 is configured such that different obturator heads can be interchangeably attached to the obturator body 79, several of which are shown as examples in inset 110, that can be used during an invasive medical procedure. In inset 110, obturator head 114 has a sharp tip and is typically used to penetrate muscle or bone, while obturator head 116 has a smooth tip and can be used to penetrate brain tissue.

As can be further seen, the obturator body 79 and the replaceable obturator heads 114, 116 are designed with recesses 113, 115, and 117, respectively, so that they can be easily fitted (e.g., inserted) into the cannula 69, with the recesses 113, 115, and 117 matching the profile of the channel 70 (see FIG. 2).

The trocar 38 configuration of FIG. 4 is shown as an example for conceptual clarity. In other embodiments, additional elements may be included, such as additional types of interchangeable obturator heads.

Figure 5 is a flow chart that generally illustrates a method of using the trocar of Figure 4 having interchangeable obturator heads (114, 116) in accordance with one embodiment of the present invention. The process begins with the physician 24 selecting a brain trocar 38 to access the brain in a trocar selection step 120.

Next, the physician 24 selects an interchangeable obturator head capable of penetrating bone, such as the interchangeable obturator head 114, in an obturator head selection step 122. In an obturator preparation step 124, the physician attaches the selected obturator head 114 to the obturator 60.

In treatment step 126, the physician 24 uses the assembled obturator to begin an invasive procedure, such as penetrating the skull using the obturator.

To continue placement of the obturator into the brain, physician 24 selects an obturator head 116 configured to enter the brain tissue in an obturator head selection step 128. In an obturator head replacement step 130, physician 24 replaces obturator head 114 with obturator head 116. Finally, in a treatment step 132, physician 24 continues the invasive procedure by advancing the obturator within the brain tissue using the reassembled obturator.

The exemplary flow chart shown in FIG. 5 has been selected solely for conceptual clarity. In a typical embodiment, physician 24 performs additional steps such as advancing cannula 69 while tracking the position of the cannula.

Although the embodiments described herein primarily address brain procedures, the methods and systems described herein may also be used in other applications requiring guidance of medical devices in other organs, such as those located in the abdomen or thorax.

Therefore, it will be understood that the above embodiments are cited by way of example, and that the present invention is not limited to what has been particularly shown and described above. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof not disclosed in the prior art that would occur to one skilled in the art upon reading the foregoing description. Documents incorporated by reference into this patent application should be considered an integral part of this application, provided that, to the extent that any term is defined in these incorporated documents in a manner that is inconsistent with a definition expressly or impliedly made herein, only the definition in this specification should be considered.

[Embodiment]
(1) A trocar for insertion into a patient's organ, comprising:
a cannula having a longitudinal axis;
a channel within the cannula and oriented parallel to the longitudinal axis;
a camera disposed at a distal end of the channel and configured to provide an image in the direction of a distal opening of the cannula;
A trocar.
(2) The trocar of claim 1, wherein the camera is tilted relative to the longitudinal axis to have a line of sight that captures a distal opening of the cannula.
3. The trocar of claim 1, further comprising a position sensor disposed at a distal end of the channel without obstructing a field of view of the camera and configured to generate a signal indicative of a position of the distal end in the organ.
4. The trocar of claim 3, wherein the position sensor is a magnetic position sensor.
(5) A system comprising:
1. A trocar for insertion into an organ of a patient, comprising:
a cannula having a longitudinal axis;
a channel within said cannula and oriented parallel to said longitudinal axis;
a trocar including a camera disposed at a distal end of the channel and configured to provide an image in the direction of a distal opening of the cannula; and a position sensor disposed at the distal end of the channel without obstructing the field of view of the camera and configured to generate a signal indicative of the position of the distal end in the organ;
a processor configured to estimate the position of the distal end of the trocar in the organ using the signals generated by the position sensor;
A system comprising:

(6) The processor further comprises:
based on the estimated position, registering the image acquired by the camera to a reference medical image; and
6. The system of claim 5, configured to present to a user the image acquired by the camera and the reference medical image, which are aligned with each other.
7. The system of claim 5, wherein the position sensor is a magnetic position sensor.
(8) A method comprising the steps of:
Inserting a trocar into an organ of a patient, the trocar comprising:
a cannula having a longitudinal axis;
a channel within said cannula and oriented parallel to said longitudinal axis;
a camera disposed at a distal end of the channel and configured to provide an image in the direction of a distal opening of the cannula; and a position sensor disposed at the distal end of the channel without obstructing the field of view of the camera and configured to generate a signal indicative of the position of the distal end in the organ.
Including,
And,
estimating the position of the distal end of the trocar in the organ using the generated signals; and
A method comprising:
(9) registering the image acquired by the camera to a reference medical image based on the estimated position;
presenting to a user the image acquired by the camera and the reference medical image, the images being registered with each other;
9. The method of claim 8, comprising:
10. The method of claim 8, wherein the position sensor is a magnetic position sensor.

Claims (6)

1. A trocar for insertion into an organ of a patient, comprising:
a cannula having a longitudinal axis;
a channel within the cannula and oriented parallel to the longitudinal axis;
a camera disposed at a distal end of the channel and configured to provide an image in the direction of a distal opening of the cannula;
an obturator comprising an obturator body configured to be inserted into the cannula, the obturator body comprising a recess configured to match a profile of the channel;
A trocar. The trocar of claim 1, wherein the camera is tilted relative to the longitudinal axis to have a line of sight that captures the distal opening of the cannula. The trocar of claim 1, further comprising a position sensor disposed at a distal end of the channel without obstructing the camera's field of view and configured to generate a signal indicative of the position of the distal end in the organ. The trocar of claim 3, wherein the position sensor is a magnetic position sensor. 1. A system comprising:
1. A trocar for insertion into an organ of a patient, comprising:
a cannula having a longitudinal axis;
a channel within said cannula and oriented parallel to said longitudinal axis;
a trocar including a camera disposed at a distal end of the channel and configured to provide an image in the direction of a distal opening of the cannula; and a magnetic position sensor disposed at the distal end of the channel without obstructing the field of view of the camera and configured to generate a signal indicative of the position of the distal end in the organ;
a processor configured to use the signals generated by the magnetic position sensor to estimate the position of the distal end in the organ based on the response of the magnetic position sensor to a magnetic field generator positioned at a fixed, known location on the patient ;
an obturator comprising an obturator body configured to be inserted into the cannula, the obturator body comprising a recess configured to match a profile of the channel;
A system comprising: The processor further comprises:
based on the estimated position , aligning the image acquired by the camera to a reference medical image; and
The system of claim 5 , configured to present to a user the image acquired by the camera and the reference medical image, registered to one another.

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